Safety and Performance of New 2-piece Ostomy Product Concept Compared With SenSura Click in Subjects With Ileostomy

Coloplast

Status: Completed

Conditions: Subjects With an Ileostomy

Treatments: Device: Coloplast C; Device: SenSura Click; Device: Coloplast B; Device: Coloplast A

Study type: Interventional

Funder types: Industry

Identifiers

NCT01800890

CP234

Details and patient eligibility

About

The aim of the current clinical investigation is to evaluate the performance and safety of new 2-piece ostomy product concepts.

Full description

The new products have been developed to reduce the degree of leakage and other problems related to ostomy appliances in people with a stoma.

Enrollment: 31 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Have given written informed consent and signed letter of authority form.
2. Be at least 18 years of age and have full legal capacity.
3. Be able to handle the appliances themselves
4. Have an ileostomy with a diameter between 15 and 40 mm.
5. Have had their ostomy for at least three months.
6. Use minimum 1 baseplate every third day.
7. Currently use 2-piece flat mechanical coupling product with open bag and a coupling size in the inter val of 43-55mm (both extremes included)
8. Must be able to use custom cut product
9. Accept to test three 2-piece products within the study.
10. Negative result of a pregnancy test for women of childbearing age.

Exclusion criteria

1. Use irrigation during the study (flush the stoma with water).
2. Currently receiving or have within the past 2 months received radio- and/or chemotherapy.
3. Currently receiving or have within the past month received local or systemic steroid treatment in the peristomal area.
4. Are pregnant or breastfeeding.
5. Participating in other interventional clinical investigations or have previously participated in this investigation.
6. More than three days wear time as usual change pattern.
7. Currently using ostomy belt
8. Currently using extended wear product (Sensura Xpro, Assura TERA, Dansac NovaLife X3, Hollister Flextend, Convatec Durahesive)
9. Have a loop ileostomy
10. Known hypersensitivity towards any of the test products
11. Suffer from peristomal skin problems that preclude participation in the investigation (assessed by the investigation nurse)

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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31 participants in 3 patient groups

Treatment sequence 1

Other group

Description:

Subjects randomised to Treatment sequence 1 will test three different products: Coloplast A Coloplast B SenSura Click The subjects test the three test products in a randomized order: ABS; BSA, SAB

Treatment:

Device: Coloplast A

Device: Coloplast B

Device: SenSura Click

Treatment sequence 2

Experimental group

Description:

Subjects randomised to Treatment sequence 2 will test three different products: Coloplast C (C) Coloplast B (B) SenSura Click (S) The subjects test the three test products in a randomized order: CBS; BSC, SCB

Treatment:

Device: Coloplast B

Device: SenSura Click

Device: Coloplast C

Treatment sequence 3

Experimental group

Description:

Subjects randomised to Treatment sequence 3 will test three different products: Coloplast A (A) Coloplast C (C) SenSura Click (S) The subjects test the three test products in a randomized order: ACS; CSA, SAC

Treatment:

Device: Coloplast A

Device: SenSura Click

Device: Coloplast C